Tag Archives: quality management system

The benefits of ISO 9001 are not overstated; companies large and small have obtained great benefits from the use of this standard by discovering cost and efficiency savings. Here are the explanations of six main benefits and why they are important:

Improvement of your credibility and image – Because ISO 9001 is an internationally recognized standard, it has become the basis for creating a quality management system around the world. When a company is looking for a supplier, it is often necessary to have a QMS based on ISO 9001 to be considered. Getting ISO 9001:2015 Certification can be a powerful marketing tool.

Improvement of customer satisfaction – One of the principles of quality management that underlies the ISO 9001 requirements is to improve customer satisfaction by planning and trying to meet customer requirements.

Improve process integration – By observing the overall process interactions through the ISO 9001 process approach, improvements in efficiency and savings can be found more easily. This is done by eliminating the waste that might occur during the process transfer.

Improve your evidence for decision making – A second quality management principle of ISO 9001 is the need to use evidence-based decision making. In addition, by monitoring the process that is improving, you can see how much improvement has occurred based on the data.

Create a continual improvement culture – Continual improvement is a third quality management principle of ISO 9001. By adopting this culture to improve organizational processes and result, you will find efficiencies and cost savings, including the use of systematic processes in case of problems reduce the impact of the problem and increase the speed of recovery. By making this continuously, improving year after year, the company can see continuing benefits from this.

Employees Engagement – Employees who participate in the process improvements they work with are happier and more engaged. Engaged employees are more productive and will help the company better improve and save, especially when they understand how the quality of the process depends on them.

With the release of ISO 9001:2015, there is a new requirement for the identification and assessment of risks and opportunities for the Quality Management System (QMS). These new requirements have created confusion not only about what should be done, but also about in ISO 9001:2015 documentation, what should be documented about risks and opportunities for your QMS. There are a few activities that must be carried out in relation to the risks and opportunities of the QMS:

Identify the risks and opportunities – what should be addressed to ensure that your QMS does what is necessary, is based on the desired results, prevents or reduces the results of the problem and obtains an improvement?

Plan your response – What actions should you take to address the risks and opportunities identified?

Integrate into your QMS – how can these plans be adopted and adapt to the usual activities so that they can happen easily?

Evaluate effectiveness – How will you know if your actions have worked, or need to be updated? This involves analyzing the information and management review to assess the effectiveness.

Do you need a document ISO 9001:2015 procedure?

It is important to note that there is no mandate for documented information for any of these steps. The standard itself does not state that it is necessary to document ISO 9001:2015 procedures that concerning risks and opportunities, just that you must perform the processes in the section above, as well as update the risks and opportunities as an outcome of process non-conformities.

For instance, you could choose to assess your risks and opportunities at a management meeting, identify a risk, decide what you want to do and make sure that employees who are executing the QMS process are aware of what they need to do and you could then claim that you are compliant with the ISO 9001:2015 requirements, even if none of these are written.

Therefore, in accordance with ISO 9001: 2015, a documented procedure is not required, but your company may have a different need for documented information and records regarding QMS risks and opportunities.

One of the first things to do when implementing a Quality Management System using the requirements of the ISO 9001:2015 standard is to write a Quality Policy for your company. Quality policy should be a brief statement that shows a commitment by top management to the quality management system.

One reason to create and implement a quality policy for your organization is to ensure that all staff are aware, aligned and supported their intentions on quality management. Another reason is because it is a requirement of ISO 9001:2015 Certification. In some ways, it seems a simple process; however, in other ways, making sure that the policy is effective in helping your company succeed can seem like an overwhelming task. You may be wondering: what are the important things to consider when creating the quality policy of our company?

Start with Customer Requirements

The key to starting any quality management system is to make sure that you understand customer requirements. If you want to successfully promote your QMS to improve customer satisfaction, it is essential to ensure that you understand all the requirements you need to meet to achieve it. These requirements may come directly from customer specification, through industry standards, or even through legal requirements related to their products or services. Making sure you have all these necessary inputs will help you ensure that your quality policy focuses on the important elements to achieve customer satisfaction.

Collect Inputs of Internal Parties

The quality policy is the main objective of the quality management system and is designed so that all employees can use it as a reference point for their work. In this case, it is important to gather input from all areas of the company to ensure that the Quality Policy is applicable to all those areas. In order to do this, it is important to get the input of people in the areas who will need to apply the policy.

Include Required Information of ISO 9001:2015

The standard does impose some requirements on the Quality Policy that are important to note. The quality policy must demonstrate the company’s commitment to meeting the requirements and improving the efficiency of the QMS.

Write and Communicate the Quality Policy

With all of this information in mind, you need to draft a policy that can guide the organization and provide direction to create quality objectives It is said that a good quality policy is simple, concise and easy to remember when under pressure. It is important that all employees not only know the policy, but also understand what it means and how their work supports compliance with the Quality Policy.

The Implementation of ISO 9001:2015 Certification is not an easy task and once the certification has passed successfully, it may seem that most of the work is done. Once you have started maintaining the QMS, you will see that certification approval is not a problem or stressful if all the required tasks are performed by the standard.

Very often, companies are not sure what to do before the surveillance audit, and therefore do not collect the information they need or do the required activities. Usually this involves calling the ISO 9001:2015 consultant to make a correction and formally assisting them to pass the certification audit.

Go from Plan to Do phase

Development procedures are easier to implement. Make sure the procedures are followed lasts longer than writing. Once the procedures are written, it will take some time to train employees to follow them. Of course, most of the activities have already been done without standard, but new ones take time to be adopted by employees.

Training

As mentioned earlier, new activities will surely require further training of employees. The good news is that the standard provides the organization with a picture of how to identify the needs and plan the training together with the requirements to measure the effectiveness of the training. A systematic approach to skills will help the organization not only achieve it with respect to standard requirements, but also for other processes

Monitoring and measuring

Monitoring and measurement should provide information on the status of a system, process, or activity within the quality management system. If you properly configure the monitoring and measurement process, it will provide process performance information. Otherwise, this is something that should be considered during the next revision of the management.

Customer satisfaction

Being one of the most important principles behind ISO 9001, customer attention is demonstrated through monitoring and measuring customer satisfaction. The company must define the frequency with which it will conduct inquiries to determine the level of customer satisfaction.

Check and Act phases

Collecting relevant information about the system through monitoring and measuring and following process procedures allows senior management to exercise the ultimate principle of ISO 9001, and decision-making on the basis of testing. A detailed and thorough internal review will provide you with more information not only on the level of compliance but also on the condition of the entire system.

External audit without stress

Having all of these system elements in place means having the actual QMS, which really works for the company. All of these elements are also the first place where auditors will be examined, so having this cover will prepare for the best review of any consultant.

The ISO 9001:2008 Certification for Quality Management System enable you to demonstrate your dedication to quality and client happiness, and additionally ceaselessly enhancing your company’s operations. The internationally recognized quality management system standard is certainly the well-liked resolution for about organizations in one hundred seventy five countries.

Overall, the consequence of the requirements of the quality would be to lower the instances wherever ISO 9001 documented procedures are obligatory and to permit the organization the liberty to determine the kind and extent of documentation required to secure the operation of the processes that comprise the standard management system.

Benefits of ISO 9001:2008

Establishes and streamlines processes through complete documentation

Improves and establishes coaching processes

Defines roles and responsibilities

Greatly will increase operational potency

Increases chance to troubleshoot

Develops and builds relationships to assist to retain existing client

Provide blessings over competitors that don’t seem to be certified ISO 9001:2008

Builds opportunities for world commerce with international recognition

Improves client relations

Improves relationships with suppliers ensuing from clear, epigrammatic production standards

Carefully planned enhancements, as made public by documentation and analysis

Provides for normal audits/reviews of performance

Increases productivity with maximizing quality

Increases revenue with Improves worker morale and satisfaction

Saves money

Enhances chance to draw in customers World Health Organization have adopted needs for certification

Improves responsibility of management

Increases employees’ information of their roles in success of their work similarly because the company

The ISO offers one among the known management systems within the world. Overall, the systems are enforced by quite one million organizations in many countries. The ISO 9001 certified company follows tips set by the organization. The standards represent the foremost comprehensive existing nowadays, and are a tried and tested framework for firms to higher make sure that they’re meeting the wants of their several purchasers.

Requirements – Documentation

In order to be ISO 9001 compliant, an authorized company giving services or product should be in possession of documented statements of a top quality policy that delineates the standard objectives.

Quality Manual

A company seeking ISO 9001 certification should possess a top ISO 9001 quality manual that sets forth the scope of the standard management system and documented procedures for addressing quality problems.

Control of Documentation

Documentation should be controlled therefore on make sure the documents are approved before being issued. Additionally, all documentation should be unbroken up-to-date. Revisions should be resubmitted for approval once an amendment is formed.

Management Responsibility

Although the ISO 9001 produces the management standards, it’s the responsibility of the corporate to self-audit. Additionally, the corporate might permit customers to perform an audit likewise. To be certified as compliant, businesses management practices should be reviewed by a freelance ISO 9001 quality system certification company.

Measurement and Analysis

Per Section eight of the ISO standards, an organization should set up and implement “the watching, measure, analysis and improvement processes” that are required to demonstrate conformity to product necessities, guarantee conformity of the standard management system, and to supply continual improvement of the standard management necessities.

Continual Improvement

In order to stay compliant with the ISO standards, an organization should frequently develop and improve its own tips to make sure corrective and preventative measures are in situ to contend with any nonconformity that will arise.

The primary purpose of an ISO 9001 registration audit is to verify that a company has quality management system (QMS) in situ that meet the explicit needs of ISO 9001:2008. The registrars are specifically trained to not come in their opinions or suggest solutions to general issues. Their job is to rigorously compare ISO 9001:2008 documentation, records, and activities to the wants of ISO 9001:2008 and verify correspondence with the quality. Though’ the auditors get data from the auditor, they primarily work severally to judge the extent of correspondence with the quality. Audi tees square measure sagely inspired by the organization to easily answer the question that’s asked so quietly sit up for following question. Auditors aren’t inspired to volunteer data to the registrar.

The purpose of a provider audit is to verify that the provider has systems and processes in situ to confirm that the customer’s specific requirement is met. Auditors once more judge documents, records and activities to confirm that explicit quality management system requirements are met also as such as product of service needs. The auditors are once more suggested to not volunteer any data on the far side responsive those queries that the auditor specifically asks.

Those organization that have complete the worth of ISO 9001:2008 internal auditing have discovered that the iso 9001 internal audit could be a completely different animal than the external audit, which ought to be performed of the audit is dong opportunities for improvement and secondary purpose is to take care of the ISO 9001 the internal auditor brings only half the knowledge to the table that is required for a successful audit – familiarity with the standard, knowledge of the organization documentation and a fresh perspective. The auditor brings the opposite half the specified data experience on the method being audited, the 2 parties square measure inspired the work along to spot those processes that aren’t engaging at their nest so action is taken to enhance them. Such an approach to internal auditing needs a major culture amendment in most organization.